Health TrialsbyHealthPanel

A Study of IBI3016 in Japanese Participants

ConditionHypertension
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Male or female participants aged 18-75 years (inclusive) at the time of informed consent;

2. Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin;

3. Office mean sitting SBP≥ 140 mmHg and < 170 mmHg at screening

Disqualifiers

1. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea;

2. History of orthostatic hypotension

3. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor

4. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI3016 Dose 4

    Drug

    single doses of IBI3016 administered by subcutaneous injection

  • IBI3016 Dose 3

    Drug

    single doses of IBI3016 administered by subcutaneous injection

  • IBI3016 Dose 2

    Drug

    single doses of IBI3016 administered by subcutaneous injection

  • IBI3016 Dose 1

    Drug

    single doses of IBI3016 administered by subcutaneous injection

  • Placebo

    Drug

    single doses of IBI3016 administered by subcutaneous injection

Treatment groups

30 Participants
are divided into 5 treatment groups
Group A: IBI3016 Dose1Experimental treatment 1 intervention
Group B: IBI3016 Dose 2Experimental treatment 1 intervention
Group C: IBI3016 Dose4Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Group E: IBI3016 Dose3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events

Time frame
Through 24 weeks, up to approximately 12 months

Secondary outcomes

1

Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016

Time frame
Predose, early post-dose and up to 48 hours postdose
2

Plasma PK: Area Under the Concentration Versus Time Curve (AUC) of IBI3016

Time frame
Predose, Day 1, and up to 48 hours postdose
3

Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessed by OBP and ABPM

Time frame
Baseline, Month 3 and Month 6
4

Change from baseline in serum angiotensinogen (AGT) concentration

Time frame
Through 24 weeks, up to approximately 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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